Transfer to BSI

Recruitment opportunities

MDR and IVDR Critical Update:

BSI has submitted designation applications for the Medical Devices Regulation (Regulation (EU) 2017/745) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746) to both the UK and The Netherlands Competent Authorities. 26 November 2017 was the first day that Notified Bodies were allowed to apply for designation under the MDR and IVDR, BSI were among the first wave of Notified Bodies to submit for both Regulations. The next step is for the Designating Authority, MHRA in the UK and IGJ in The Netherlands, to review our application and write a preliminary report to be sent to the Commission so that they can schedule Joint Assessment audits of BSI.

BSI is proud to work towards designation for these critical Regulations and will continue to strive for excellence in our Notified Body activities over the transition period. We will ensure that you are kept up to date with the progression going forward.

As a medical device manufacturer, there are a number of regulatory requirements you must meet before you can sell your devices on the international market. It is essential that your certification body has the capability and expertise to support you with robust product and system certification reviews, to ensure patient and user safety.

NEW: MDR Safety and Performance Requirements white paper

The Safety and Performance Requirements (SPRs) of the Medical Devices Regulation (MDR) replace the previous Directives' Essential Requirements (ERs) and outline the key areas to address within the Technical Documentation. Our new complimentary white paper provides comparison of the SPRs and ERs, allowing you to understand what's changing in more detail.

Our commitment to excellence

We understand the specific challenges medical device manufacturers face and the importance of bringing innovative yet safe products to global markets. Ensuring the predictability and transparency of regulatory product clearance is key to maintaining a competitive edge.

We demonstrate this commitment through:

Over 2,050 years’ medical device product and regulatory experience

Internal Product Experts and Auditors

Direct access to your team of technical specialists

Our range of review services to give you flexibility

Support throughout the product lifecycle

Regardless of which phase of the product lifecycle you’re in, BSI can work with you to minimise your corporate risk and ensure you remain compliant.